Lesinurad and Febuxostat Combination Extension Study in Gout
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| ClinicalTrials.gov Identifier: NCT01808144 |
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Recruitment Status :
Completed
First Posted : March 11, 2013
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
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Sponsor:
Ardea Biosciences, Inc.
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
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Brief Summary:
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gout | Drug: lesinurad Drug: febuxostat | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 196 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Long-Term Extension Study of Lesinurad in Combination With Febuxostat for Subjects With Gout Completing an Efficacy and Safety Study of Lesinurad and Febuxostat |
| Actual Study Start Date : | March 1, 2013 |
| Actual Primary Completion Date : | August 9, 2016 |
| Actual Study Completion Date : | October 6, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Gout
MedlinePlus related topics:
Gout
| Arm | Intervention/treatment |
|---|---|
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Experimental: lesinurad 400 mg + febuxostat 80 mg
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
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Drug: lesinurad
Tablets, 400 mg once daily (QD) Drug: febuxostat Tabletsm 80 mg QD |
| Experimental: lesinurad 200 mg + febuxostat 80 mg |
Drug: lesinurad
Tablets, 200 mg QD Drug: febuxostat Tabletsm 80 mg QD |
Primary Outcome Measures :
- Percentage of Participants With an sUA Level That is < 5.0 mg/dL [ Time Frame: Up to approximately 2.5 years (at Extension Month 12) ]Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
Secondary Outcome Measures :
- Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus [ Time Frame: Up to approximatley 2.5 years (at Extension Month 12) ]Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
- Subject completed the double-blind treatment period in Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit.
- Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.
Exclusion Criteria:
- Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808144
Locations
Show 72 study locations
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
| Study Director: | Nihar Bhakta, MD | Ardea Biosciences, Inc. |
| Responsible Party: | Ardea Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01808144 |
| Other Study ID Numbers: |
RDEA594-307 2012-004390-54 ( EudraCT Number ) |
| First Posted: | March 11, 2013 Key Record Dates |
| Results First Posted: | January 30, 2018 |
| Last Update Posted: | January 30, 2018 |
| Last Verified: | January 2018 |
Keywords provided by Ardea Biosciences, Inc.:
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Gout |
Additional relevant MeSH terms:
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Gout Arthritis Joint Diseases Musculoskeletal Diseases Crystal Arthropathies Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors |
Genetic Diseases, Inborn Metabolic Diseases Febuxostat Lesinurad Gout Suppressants Antirheumatic Agents Uricosuric Agents |